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NCT Number: NCT04560140

Promoting Community Reintegration for Young Adults With Stroke

This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. Participants will be facilitated to narrate their survival experiences and rebuild core life skills. Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) are 18-64 years of age,
  • (2) have a clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke,
  • (3) are living at home after discharge from hospital,
  • (4) have a Montreal Cognitive Assessment score >20,
  • (5) have a modified Rankin Scale score ≥3,
  • (6) can communicate in Cantonese, and
  • (7) are able to attend all intervention sessions.

Exclusion criteria

  • 1) transient ischaemic attack, subdural or epidural haemorrhage,
  • 2) experienced cerebrovascular events due to tumours or head trauma,
  • 3) mental condition such as depression, schizophrenia, bipolar or personality disorder,
  • 4) incomprehensible speech or difficulty in comprehending conversations, or
  • 5) have received a self-management programme in the past.

Treatment and study plan

Narrative and Skills-building Intervention

Behavioral

The intervention is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation. It will consist of eight individual sessions over six months delivered by a facilitator. Participants will be facilitated to narrate their survival experiences and rebuild core life skills.

Primary outcomes

  1. Change in the participants' level of community reintegration

    Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

    The Chinese version of the Reintegration to Normal Living Index (RNIL-C) will be used to assess the participants' level of community reintegration. It consists of 11 items in eight domains: mobility, self-care, daily work and school activity, recreational and social activities, family roles, personal relationships, presentation of self to others and general coping skills. Participants are asked to rate the extent to which each item describes their situation on a scale from 1 - 'a small extent' to 5 - 'a great extent'. The total score is calculated by summation and normalised to give 100 with a total score range of 25 to 100. A higher score indicates better community reintegration. The RNIL-C has high internal consistency (Cronbach's alpha=0.92) and good convergent validity.

Secondary outcomes

  1. Change in the participants' level of depressive symptoms

    Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

    The Chinese version of the 15-item Geriatric Depression Scale (GDS) will be used to measure participants' depressive symptoms. Studies support its utility in younger adults (>18 years old), with good diagnostic sensitivity and specificity. Each item represents symptoms of depression and describes a participant's condition in the preceding week; the participants answer each item with either 'yes' or 'no'. All items are summed (total score 0-15). A score of six or greater is a cutoff for depression. The GDS has a Cronbach's alpha of 0.78.

  2. Change in the participants' level of health-related quality of life

    Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

    Participants' health-related quality of life (HRQoL) will be measured by the Chinese version of the Stroke-Specific Quality of Life Scale (SSQOL-C), which has 47 items with 11 domains ranging from physical to psychosocial and participation. The items are about the health conditions of the participants and how much difficulty the participants have when doing everyday self-care tasks. The items are scored from 1 - 'strongly disagree/cannot do it' to 5 - 'strongly agree/no trouble'. Total score is yielded by summing all item scores (range 47-235): the higher the score, the higher the HRQoL. It has acceptable internal consistency (Cronbach's alpha: 0.63-0.93) and convergent validity.

  3. Change in the participants' level of satisfaction with the performance of self-management behaviours

    Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

    The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale (SSBPS-C) will be adopted to assess participants' satisfaction with the performance of self-management behaviours. Each item is scored using a range from 0 - 'very dissatisfied' to 10 - 'very satisfied'. Taking the sum of all item scores yields one total score (range 0-110), and the higher the score, the higher the satisfaction. This scale has a Cronbach's alpha of 0.93.

  4. Change in the participants' level of self-efficacy

    Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

    The Chinese version of the Stroke Self-Efficacy Questionnaire (SSEQ-C) will be used to measure self-efficacy. It has 13 items, each is scored using a scale from 0 - 'no confidence' to 10 - 'very confident'. The items are about the participants' perceived extent of confidence in doing everyday activities and self-management tasks. A total score is yielded by summing all items (range 0-130). A higher total score represents higher self-efficacy. The scale has acceptable internal consistency (Cronbach's alpha=0.92) and convergent validity.

  5. Change in the participants' level of outcome expectation

    Time frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

    The Chinese version of the Stroke Self-management Outcome Expectation Scale (SSOES-C) will be used to measure the participants' outcome expectation beliefs. It has 11 items, each rated using a scale from 0 - 'strongly disagree' to 10 - 'strongly agree'. The score of each item indicates the participants' confidence in the expected outcomes to occur. All item scores will be calculated by summation (total score 0-110). A higher score represents higher outcome expectations. This scale has good internal consistency (Cronbach's alpha=0.94).

Study contacts

Contact information is provided by the study sponsor or research team.

Suzanne Lo

CONTACT

[email protected]

852 39434485

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2020
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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